Effective Date: 03/29/2026 (see HHSAR CD 2026-02 Amendment 1)
Subpart 335.70 – Acquisitions Involving Human Subjects
335.7000 Scope of subpart.
335.7001 Policy.
335.7002 Federal-wide Assurance (FWA).
335.7003 General procedures.
335.7004 Solicitation provision and contract clauses.
Subpart 335.71 – Acquisitions Involving the Use of Laboratory Animals
335.7100 Scope of subpart.
335.7101 Policy.
335.7102 Assurances.
335.7103 General procedures.
335.7104 Solicitation provision and contract clause.
Subpart 335.70 – Acquisitions Involving Human Subjects
335.7000 Scope of subpart.
This subpart implements the Federal Policy for the Protection of Human Subjects adopted by HHS at 45 CFR part 46 and applies to all research activities conducted under contracts involving human subjects.
335.7001 Policy.
(a) The HHS Office for Human Research Protections (OHRP) administers the assurance covering all HHS-supported or HHS-conducted activities involving human subjects.
(b) The contracting officer must not award a contract involving human subjects until the prospective contractor provides assurance that the activity will undergo initial and continuing review by an appropriate Institutional Review Board (IRB) to the extent required by HHS regulations at 45 CFR part 46.
(c) The contracting officer must require a Federal-wide assurance (FWA), approved by OHRP, of each contractor, subcontractor, or institution engaged in human subjects research in performance of a contract.
335.7002 Federal-wide Assurance (FWA).
(a) OHRP-Approved FWAs are available at http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc.
(b) A contractor, subcontractor, or institution must submit all FWAs (including new submissions, updates, and renewals) using the electronic submission system available through the OHRP website at http://ohrp.cit.nih.gov/efile/. If a contractor, subcontractor, or institution cannot submit its FWA electronically, it must contact OHRP by telephone or email (see https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/contact/index.html) and explain why a FWA cannot be submitted electronically.
335.7003 General procedures.
(a) Normally a contractor, subcontractor, or institution must provide approval of a FWA before a contract is awarded.
- (1) If a contractor, subcontractor, or institution does not currently hold an approved FWA, it must submit an explanation with its proposal and an FWA application prior to submitting a proposal.
- (2) The contracting officer, on a case-by-case basis, may make award without an approved assurance in consultation with OHRP.
(b) The contracting officer generally will not request FWAs for contractors, subcontractors, or institutions prior to selecting a contract proposal for negotiation.
- (1) When a contractor submits an FWA, it provides certification for the initial contract period; no additional documentation is required.
- (2) If the contract provides for additional years to complete the project, the contractor must certify annually in accordance with HHSAR 352.235-71. Unless otherwise stated, the annual certification must be provided on/by the anniversary date of the contract award.
(d) Additional review and approval requirements. If research involving human subjects is subject to reviews and approvals that are not outlined in this subpart or the prescribed provisions and clauses, these requirements will be specified in the contract.
335.7004 Solicitation provision and contract clauses.
(a) Insert the provision at 352.235-70, Notice of Offerors – Protection of Human Subjects, in solicitations that involve or may involve human subjects. Use the provision with its Alternate I when the agency is prescribing a date later than the proposal submission by which the offeror must have an approved FWA.
(b) Insert the following clauses in solicitations, contracts, and orders that involve or may involve human subjects:
- (1) 352.235-71, Protection of Human Subjects.
- (2) 352.235-72, Needle Exchange.
- (3) 352.235-73, Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research.
Subpart 335.71 – Acquisitions Involving the Use of Laboratory Animals
335.7100 Scope of subpart.
This subpart applies to all research, research training, biological testing, housing and maintenance, and other activities involving live vertebrate animals conducted under contract. Additional information can be found in Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) at http://grants.nih.gov/grants/olaw/references/phspolicylabanimals.pdf.
335.7101 Policy.
(a) The National Institutes of Health (NIH), Office of Laboratory Animal Welfare (OLAW) negotiates assurances covering all HHS/PHS-supported or HHS/PHS-conducted activities involving the care and use of live vertebrate animals.
(b) Contracting officers must—
- (1) Not award a contract involving live vertebrate animals until the contractor provides acceptable assurance that the contract work is subject to initial and continuing review by an appropriate Institutional Animal Care and Use Committee (IACUC) as described in the PHS Policy at IV.B.6 and 7.
- (2) Require an applicable Animal Welfare Assurance approved by OLAW of each contractor, subcontractor, or institution having responsibility for animal care and use involved in performance of the contract.
- (i) The assurance must be approved before award; however, the contracting officer, on a case-by-case basis, may make a contract award without an approved assurance in consultation with OLAW. For additional information see PHS Policy II., IV.A, and V.B.
(c) Offerors proposing use of live vertebrate animals must address all required elements in the Vertebrate Animals Section (VAS) of the Technical Proposal. For additional information see PHS Policy and use Contract Proposal VAS Worksheet. See https://olaw.nih.gov/policies-laws/phs-policy.htm#InformationRequiredinApplications-ProposalsforAwardsSubmittedtoPHS and http://grants.nih.gov/grants/olaw/VAScontracts.pdf.
335.7102 Assurances.
(a) Animal Welfare Assurances include:
- (1) Domestic Assurance (DA). A DA describes the institution's animal care and use program, including but not limited to the lines of authority and responsibility, veterinary care, IACUC composition and procedures, occupational health and safety, training, facilities, and species housed. A DA listed in OLAW's list of institutions with an approved DA is acceptable for purposes of this policy.
- (2) Inter-institutional Assurance (IA). The offeror, its proposed subcontractor, or institution must submit an IA when it does not have a proprietary animal care and use program, facilities to house animals or IACUC, and does not conduct animal research on-site. The offeror will perform the animal activity at an institution with an Animal Welfare Assurance named as a performance site. An IA approval extends to the full period of contract performance (up to 5 years) limited to the specific award or single project.
- (3) Foreign Assurance (FA). The Foreign Assurance is required for institutions outside the U.S. that receive PHS funds directly through a contract award. The Foreign Assurance also applies to institutions outside the U.S. that receive PHS funds indirectly (named as a performance site). An FA listed in OLAW's list of institutions with an approved FA is acceptable for purposes of this policy.
(b) Contractors providing animal care services at an institution with an Animal Welfare Assurance, such as a Government-owned, Contractor-operated (GOCO) site, does not need a separate assurance if covered by the site’s assurance.
335.7103 General procedures.
(a) Offerors having a DA on file with OLAW must submit IACUC approval of the use of animals in the manner required by the solicitation, but prior to award. The date of IACUC approval must not be more than 36 months prior to award.
(b) It is not necessary for offerors lacking an Animal Welfare Assurance to submit assurances or IACUC approval with proposals. OLAW will contact contractors, subcontractors, and institutions to negotiate necessary assurances and verify IACUC approvals when requested by the contracting officer.
(c) Contracting officers must send proposals selected for negotiation and requiring an assurance to OLAW at olawdoa@od.nih.gov, as early as possible to secure the necessary assurances.
(d) Normally the assurance must be approved before award. The contracting officer, on a case-by-case basis, may make award without an approved assurance in consultation with OLAW. For additional information see PHS Policy II., IV.A, and V.B.
335.7104 Solicitation provision and contract clause.
(a) Insert the provision at 352.235-74, Notice to Offerors – Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, in solicitations involving live vertebrate animals.
(b) Insert the clause at 352.235-75, Care of Live Vertebrate Animals, in solicitations, contracts, and orders involving live vertebrate animals.